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Terminated

AxiEM EM Knee Kit, and associated workstation.

FDA Recall Z-0718-06 · Posted 2006-04-07

Recalling FirmMedtronic Navigation, Inc
Recall StatusTerminated
Product CodeHAW
Date Initiated2006-02-01
Date Terminated2006-04-06
Product Quantity84 kits

Reason for Recall

Knee Navigation Disposable Kits were programmed with an incorrect identification number on the tracker ROM chip which would not permit navigation during surgery.

Firm Action

Medtronic field personnel were notified by letter on 02/01/2006 and instructed to immediately contact each affected site and schedule an upgrade with the revised firmware

Root Cause

Other

Distribution Pattern

AZ, CA, CO, GA, IL, LA, MT, NE, NV, OH, TX. No military or government distribution. Foreign distribution to Australia, Austria, Israel, Singapore, Switzerland, UK.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K043088MEDTRONIC SNT STEALTHSTATION AXIEM IMAGELESS KNEE MODULEMedtronic Surgical Navigation Technologies · 2005-01-05K001284STEALTHSTATION SYSTEM GOLDENEYE MICRO-MAGNETIC TRACKING SYSTEMMedtronic Surgical Navigation Technologies · 2000-06-12

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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